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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000047997 |
Receipt No. | R000054700 |
Scientific Title | Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients |
Date of disclosure of the study information | 2022/06/15 |
Last modified on | 2022/06/08 |
Basic information | ||
Public title | Impact of music therapy in post-stroke aphasia patients | |
Acronym | Impact of music therapy in post-stroke aphasia patients | |
Scientific Title | Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients | |
Scientific Title:Acronym | Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients | |
Region |
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Condition | ||
Condition | Post-stroke aphasia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | An initial investigation into whether listening to music with lyrics improves aphasia in subacute stroke patients, and if so, in what aphasia classifications and in what symptoms of aphasia. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The change in WAB-AQ(Western Aphasia Battery-Aphasia quotient) before and after the 3-month intervention period |
Key secondary outcomes | The change in each subset score of the WAB(Western Aphasia Battery) before and after the 3-month intervention period |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Three months of free listening to music with lyrics of the patient's choice for at least one hour per day. Every two weeks, a 15-minute interview with a physician or nurse to check and improve adherence to music listening | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | First stroke patients admitted to the Recovery Rehabilitation Unit of Murayama Medical Center, within 60 days of onset, with aphasia scoring 4 or less on the severity scale of the Boston Diagnostic Aphasia Evaluation, whose attending physician deems them appropriate and who have given written consent | |||
Key exclusion criteria | Native language is not Japanese, severe hearing impairment | |||
Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saiseikai Higashikanagawa Rehabilitation Hospital | ||||||
Division name | Department of Rehabilitation medicine | ||||||
Zip code | 221-0822 | ||||||
Address | 1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa | ||||||
TEL | 045-324-3600 | ||||||
someguya617@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Saiseikai Higashikanagawa Rehabilitation Hospital | ||||||
Division name | Department of Rehabilitation medicine | ||||||
Zip code | 221-0822 | ||||||
Address | 1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa | ||||||
TEL | 045-324-3600 | ||||||
Homepage URL | |||||||
someguya617@gmail.com |
Sponsor | |
Institute | Murayama Medical Center, department of Rehabilitation medicine |
Institute | |
Department |
Funding Source | |
Organization | Murayama Medical Center, department of Rehabilitation medicine |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Murayama Medical Center |
Address | 2-37-1 Gakuen, Musashimurayama, Tokyo |
Tel | 042-561-1221 |
218-murayamahome@mail.hosp.go.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054700 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |